Device Dossier
Orthopaedic bone pin, non-bioabsorbable
Device Dossier for Orthopaedic bone pin, non-bioabsorbable (Orthopaedic bone pin, non-bioabsorbable, Class IIb, sponsor Orthopediatrics AUS). ARTG…
- GMDN category: Orthopaedic bone pin, non-bioabsorbable
Intended purpose
A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.